AccessGUDID - DEVICE: Premier X5 Sectional Matrix System (00348783004687)

GUDID

Device Identifier (DI) Information

Brand Name: Premier X5 Sectional Matrix System
Version or Model: 9061190
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PREMIER DENTAL PRODUCTS COMPANY

Primary DI Number: 00348783004687
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014789663 *Terms of Use

Device Description: Premier X5 Ring Universal- Qty 35

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33204	Dental matrix band retainer	A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEP	Retainer, Matrix

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8fcb404b-eb9a-49d8-9cc8-92c361978d1d
Public Version Date: July 22, 2024
Public Version Number: 1
DI Record Publish Date: July 12, 2024